Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems (NCT07296263) | Clinical Trial Compass
By InvitationNot Applicable
Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems
United States85 participantsStarted 2025-12-30
Plain-language summary
This is a prospective, multi-center, interventional study designed to evaluate the visualization benefits of FDA approved gadolinium-based contrast agents (GBCAs) in portable magnetic resonance imaging (pMRI) of the brain. The study will enroll adult patients with known or suspected brain lesions involving blood-brain barrier disruption. Each participant will undergo a pre-contrast pMRI scan, receive an intravenous GBCA injection, and then complete a post-contrast pMRI scan using the Swoop® Portable MR Imaging® System. Lesion visualization will be assessed by independent neuroradiologists using standardized scoring criteria. The study will be conducted across a minimum of three sites to ensure diversity in patient population, imaging environments, and GBCA types.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
To be eligible to participate in this study, an individual must meet all the following criteria:
* Age ≥18 years Clinical indication of suspected or known brain lesion(s) with focal blood-brain barrier disruption. Preferably, at least one previously documented brain lesion with focal areas of blood-brain barrier disruption categorizable as:
* intra-axial tumor(s)
* extra-axial tumor(s)
* infection/inflammatory lesion(s)
* Cleared for portable MRI (pMRI) and intravenous GBCA administration per site policy.
* Adequate peripheral venous access for contrast injection.
* Able to provide informed consent and comply with brief supine imaging (pre- and post-contrast)
Exclusion Criteria
Participants will be excluded if they meet any of the following criteria:
* Metallic clips or devices in the brain or eye.
* Body weight greater than 200 kg.
* Inability to fit or be positioned appropriately within the Swoop® Portable MR Imaging® System.
* Inability to remain still or lie flat during the imaging period.
* Not cleared for GBCA administration due to known hypersensitivity, allergy, or contraindication.
* Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or acute kidney injury.
* History of severe reaction to any gadolinium-based contrast agent.
* GBCA administration within the prior 48 hours (or alternative clearance window defined by institution)
* Known or suspected pregnancy at the time of imaging.
* Any medical or behavioral condition that, in the inv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiologist-rated lesion border delineation on post-contrast portable MRI
Timeframe: 6 months
2
Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI
Timeframe: 6 months
3
Radiologist-rated degree of contrast enhancement of target lesions on portable MRI